Tagrisso

Chemotherapy, Non-Small Cell Lung Cancer, Pharmacotherapy + 2 more

Treatment

7 FDA approvals

20 Active Studies for Tagrisso

What is Tagrisso

Osimertinib

The Generic name of this drug

Treatment Summary

Osimertinib is an oral medication used to treat metastatic non-small cell lung cancer (NSCLC) that has spread despite treatment with other EGFR-TKIs. Around 10% of NSCLC patients have a mutation in their EGFR gene that makes them respond well to this type of drug. This third-generation EGFR-TKI is more specific than previous generations and less toxic, as it only targets the T790M mutation and spares wild-type EGFR.

Tagrisso

is the brand name

image of different drug pills on a surface

Tagrisso Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Tagrisso

Osimertinib

2015

2

Approved as Treatment by the FDA

Osimertinib, also known as Tagrisso, is approved by the FDA for 7 uses which include Metastatic Non-Small Cell Lung Cancer and Non-Small Cell Lung Carcinoma (NSCLC) .

Metastatic Non-Small Cell Lung Cancer

Non-Small Cell Lung Carcinoma (NSCLC)

Malignant Neoplasms

Failed Tyrosine Kinase Inhibitors

Non-Small Cell Lung Cancer

Chemotherapy

Pharmacotherapy

Effectiveness

How Tagrisso Affects Patients

A study found that taking osimertinib 80 mg can lead to a 14 millisecond (msec) increase in the QTc interval. However, the upper limit of this increase could be up to 16 msec.

How Tagrisso works in the body

Osimertinib is a drug used to treat non-small cell lung cancer in people with certain mutations in the EGFR gene. It is a type of tyrosine kinase inhibitor (TKI) that specifically targets the T790M mutation, which is associated with a poor prognosis. It has 200 times more affinity for this mutation than for the normal, or wild-type, EGFR gene. Osimertinib is also less likely to bind to the wild-type EGFR, reducing the risk of side effects.

When to interrupt dosage

The prescribed dosage of Tagrisso is dependent on the diagnosed condition. The exact amount varies, in accordance with the method of administration specified in the table below.

Condition

Dosage

Administration

Chemotherapy

40.0 mg, , 80.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral

Non-Small Cell Lung Cancer

40.0 mg, , 80.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral

Pharmacotherapy

40.0 mg, , 80.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral

Malignant Neoplasms

40.0 mg, , 80.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral

Failed Tyrosine Kinase Inhibitors

40.0 mg, , 80.0 mg

, Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, Tablet - Oral

Warnings

There are 20 known major drug interactions with Tagrisso.

Common Tagrisso Drug Interactions

Drug Name

Risk Level

Description

Ozanimod

Major

Osimertinib may decrease the excretion rate of Ozanimod which could result in a higher serum level.

Rimegepant

Major

The serum concentration of Rimegepant can be increased when it is combined with Osimertinib.

(R)-warfarin

Moderate

The serum concentration of (R)-warfarin can be decreased when it is combined with Osimertinib.

3,5-Diiodotyrosine

Moderate

The therapeutic efficacy of 3,5-Diiodotyrosine can be decreased when used in combination with Osimertinib.

3,5-diiodothyropropionic acid

Moderate

The therapeutic efficacy of 3,5-diiodothyropropionic acid can be decreased when used in combination with Osimertinib.

Tagrisso Toxicity & Overdose Risk

In clinical trials, 3.7% of patients reported lung problems, including fatal cases in 0.3% of patients. There is also a risk of abnormal heart rhythm, so an electrocardiogram and electrolytes should be monitored for those with a history of abnormal heart rhythms. Additionally, 3% of patients reported heart muscle damage, so it is important to measure the left ventricular ejection fraction at the beginning and during treatment. Women should also be aware that osimertinib can cause harm to unborn babies and should use effective birth control during and after treatment.

image of a doctor in a lab doing drug, clinical research

Tagrisso Novel Uses: Which Conditions Have a Clinical Trial Featuring Tagrisso?

Nine active clinical trials are presently underway to evaluate the potential of Tagrisso in treating Malignant Neoplasms.

Condition

Clinical Trials

Trial Phases

Non-Small Cell Lung Cancer

359 Actively Recruiting

Not Applicable, Phase 2, Phase 3, Phase 1, Phase 4, Early Phase 1

Pharmacotherapy

0 Actively Recruiting

Malignant Neoplasms

3 Actively Recruiting

Phase 1, Phase 2

Chemotherapy

4 Actively Recruiting

Phase 1, Phase 3, Not Applicable

Failed Tyrosine Kinase Inhibitors

0 Actively Recruiting

Tagrisso Reviews: What are patients saying about Tagrisso?

5

Patient Review

1/13/2019

Tagrisso for Non-Small Cell Lung Cancer with EGFR T790M Gene Mutation

My mom has been taking this treatment for 2.5 years and it's really helped her. She started with Tarceva and then switched to Targrisso after 18 months.

5

Patient Review

7/17/2017

Tagrisso for Non-Small Cell Lung Cancer with EGFR T790M Gene Mutation

I had been taking Tarceva for ten years and it stopped working. My CEA score started rising, so I began Tagrisso in January 2017. Unfortunately, my heart started beating too fast.

5

Patient Review

2/14/2017

Tagrisso for Non-Small Cell Lung Cancer with EGFR T790M Gene Mutation

Tarceva worked for me for six months, and then Optivo for two. Now Tegrisso is showing great improvement in my scans and tumor markers.

1.7

Patient Review

12/19/2018

Tagrisso for Non-Small Cell Lung Cancer with EGFR T790M Gene Mutation

My father died after taking this medication for only three weeks.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about tagrisso

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can Tagrisso cure lung cancer?

"AstraZeneca's Tagrisso has been approved by the US Food and Drug Administration (FDA) for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumour resection with curative intent."

Answered by AI

What kind of cancer does Tagrisso treat?

"Tagrisso is a cancer medication used to treat non-small cell lung cancer (NSCLC). It is specifically used to treat patients whose cancer cells have certain mutations in the EGFR gene."

Answered by AI

Is Tagrisso a form of chemotherapy?

"TAGRISSO is a targeted cancer therapy in pill form that is taken once a day, with or without food. Targeted cancer therapies are designed specifically to target certain types of cancer and work by blocking the growth and spread of cancer cells."

Answered by AI

Clinical Trials for Tagrisso

Image of Vanderbilt-Ingram Cancer Center in Nashville, United States.

Anti-PD-1 Immunotherapy for Cancer

18+
All Sexes
Nashville, TN

Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment and work by blocking protein interactions that normally prevent the immune system from recognizing and destroying cancer cells. However, these agents, now approved for over 15 types of cancers and for both early-stage and metastatic disease, are capable of causing inflammation in any organ system of the body that can lead to organ damage, dysfunction, and even death in rare cases. Some patients may suffer acute and treatable complications like joint pain, but some may have irreversible complications like hypothyroidism that requires daily, life-long medication. It is therefore important to fully understand the different types of damage ICIs can cause to better monitor patients receiving ICI therapy. A rising concern from recent reports in the literature is that ICIs may weaken bone and increase the risk of fractures. In this study, the investigators aim to characterize how ICIs impact the bone by examining several factors in patients undergoing curative-intent ICI treatment either alone or in combination with chemotherapy: bone mineral density, bone volume, and markers of bone turnover in the blood. The study will use two imaging techniques to assess bone mineral density and volume. DXA (dual X-ray absorptiometry) imaging uses low-dose X-rays to measure how dense (or strong) bones are and is often used to diagnose or assess the risk of osteoporosis. High-resolution peripheral quantitative computed tomography (HRpQCT) is a 3D imaging technology that can quantify bone structure and volume and offers high resolution that can be used to assess bone in smaller bones of the peripheral skeleton. The investigators hypothesize that ICI treatment will weaken bones and increase the risk of fractures. As ICI therapy is relatively new, a rising number of patients may be at risk of fractures or have low bone density that is not being monitored because there are no guidelines in place notifying physicians of this potential risk to patients. This is study will provide important preliminary data that will be the basis for larger studies in the future aiming to better monitor and potentially treat bone weakening in patients treated with ICIs to reduce the pain, inconvenience, and complications from fragility fractures.

Recruiting
Has No Placebo

Vanderbilt-Ingram Cancer Center

Image of Princess Margaret Cancer Center, University Health Network in Toronto, Canada.

Care & Connect for Lung Cancer

18+
All Sexes
Toronto, Canada

Background: In Canada, lung cancer accounts for approximately 25% of cancer deaths each year. There are also known sociodemographic and racial inequities in the diagnosis and treatment of lung cancer. Studies have consistently found that patients with cancer have a high number of unmet needs, including psychological, physical, and informational. Navigation programs represent a potentially promising, equitable, and cost-effective approach to address the unmet needs of patients with lung cancer, but there is limited evidence about their effectiveness in patients with lung cancer. The investigators developed and have implemented a volunteer lay navigator program, Care and Connect (C\&C), which aims to proactively reduce distress in patients, provide information and support, and increase access to treatment and supportive care resources. The proposed pilot randomized controlled trial (RCT) project plans to 1) assess the feasibility and acceptability of referral to C\&C and, 2) examine the preliminary effectiveness of C\&C. Methods: The current study is a 2-arm, parallel group, mixed methods, pilot RCT with a 1:1 allocation ratio and 3 timepoints: baseline (T0), 3 months (T1), 6 months (T2). It is designed to test the trial feasibility and acceptability of the C\&C intervention in patients with lung cancer. In total, 50 participants will be randomized to receive the C\&C intervention or usual care only (25 per arm). At each timepoint, data will be collected on participants' access to psychosocial (PSO) services, psychological wellbeing, and satisfaction with care through participant medical record and a survey. To gain additional insights regarding the acceptability, feasibility, and impact of C\&C, a subset of 15 participants from the intervention group will be contacted for qualitative exit interviews. Expected outcomes: There is limited evidence about the effects of lay navigation programs on access to PSO services among patients with lung cancer. This work addresses this knowledge gap by evaluating the feasibility, acceptability, and preliminary impact of C\&C on patients with lung cancer. The findings of the proposed work will expand the body of evidence supporting lay navigation to the lung cancer population, contributing to the evidence base for patient-centred care.

Waitlist Available
Has No Placebo

Princess Margaret Cancer Center, University Health Network

Gilla K Shapiro, PhD

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Image of Memorial Sloan Kettering Basking Ridge (All Protocol Activities) in Basking Ridge, United States.

Ivonescimab + Dato-DXd/Osimertinib for Lung Cancer

18+
All Sexes
Basking Ridge, NJ

The researchers are doing this study to find out whether ivonescimab in combination with datopotamab deruxtecan- (Dato-DXd) or osimertinib are safe and effective treatments in people with non-small cell lung cancer (NSCLC) that has an EGFR mutation. The researchers will test different doses of the Dato-DXd or osimertinib with an unchanging (fixed) dose of ivonescimab to find the best dose that causes few or mild side effects in participants. Once the dose is found the researchers will test ivonescimab with Dato-DXd or osimertinib in a new group of participants to see if it is effective in treating their NSCLC with an EGFR mutation.

Phase 1 & 2
Recruiting

Memorial Sloan Kettering Basking Ridge (All Protocol Activities) (+6 Sites)

Helena Yu, MD

Summit Therapeutics

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Image of Massachusetts General Hospital in Boston, United States.

Ivonescimab + Chemotherapy for NSCLC

18+
All Sexes
Boston, MA

The goal of this clinical trial is to assess the efficacy of ivonescimab monotherapy in patients with advanced non-small cell lung cancer harboring actionable genomic alterations who have received prior targeted therapies and chemotherapy. This clinical trial also aims to assess the efficacy of ivonescimab plus carboplatin/pemetrexed chemotherapy in patients with advanced non-small cell lung cancer harboring actionable genomic alterations other than epidermal growth factor receptor mutations who have received prior targeted therapies but no chemotherapy. The main questions it aims to answer are: * Will ivonescimab alone or together with carboplatin/pemetrexed chemotherapy shrink tumors in the clinical trial's patients? * Will ivonescimab alone or together with carboplatin/pemetrexed chemotherapy effectively influence if the patients' cancer grows, how long the treatment takes to start working, how long the treatment keeps working after it first starts to help, how long the treatment keeps the cancer from getting worse, and overall survival of patients? * How many patients receiving ivonescimab alone or together with carboplatin/pemetrexed chemotherapy will experience treatment-emergent, treatment-related, immune-related, and especially interesting side effects? Patients receiving ivonescimab alone will receive an intravenous infusion of ivonescimab every 3 weeks for up to 24 months. Patients receiving ivonescimab together with carboplatin/pemetrexed chemotherapy will receive separate intravenous infusions of ivonescimab, pemetrexed, and carboplatin every 3 weeks for 4 cycles (each cycle is 21 days). These patients will continue to receive infusions of ivonescimab and pemetrexed every 3 weeks for up to 24 total months.

Phase 2
Waitlist Available

Massachusetts General Hospital (+2 Sites)

Jessics J Lin, MD

Summit Therapeutics

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We made a collection of clinical trials featuring Tagrisso, we think they might fit your search criteria.
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